E9-27182. Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” The guidance document is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

DATES:

Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the guidance document entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments” to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document.

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Michele Mital, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 301-796-4800, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 21, 2009 (74 FR 54052), FDA announced the availability of a draft guidance document entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” The agency considered received comments as it finalized this guidance. This guidance document is designed to assist domestic owners and operators with submitting tobacco product establishment registration and tobacco product listing information. Under section 905(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 387e(b)), added by the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register with FDA by December 31 of each year. Moreover, all registrants must at the time of registration file with FDA a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution, along with certain accompanying information, including all labeling (see section 905(i)(1) of the act, as added by the Tobacco Control Act).

FDA does not intend to enforce the requirement to submit registration and product listing information under section 905 of the act by December 31, 2009, provided that the submission is received by FDA on or before February 28, 2010. We recognize that the forms developed by FDA are new to industry, and so may require additional time to complete accurately. While electronic submission of registration and listing information is not required, FDA is strongly encouraging electronic submission to facilitate efficiency and timeliness of data management and submission. FDA does recognize, however, that electronic submission requires several additional steps, such as obtaining an Electronic Submissions Gateway account and becoming familiar with the eSubmitter electronic application. FDA therefore believes that this additional time for the first submission of this registration and listing information should result in submission of higher quality information.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0650.

V. Electronic Access

An electronic version of the guidance document is available on the Internet at http://www.regulations.gov and http://www.fda.gov/​TobaccoProducts/​GuidanceComplianceRegulatoryInformation/​default.htm.

Dated: November 6, 2009.

David Horowitz,

Assistant Commissioner for Policy.